Nucala 100mg powder for solution for injection vials

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Mepolizumab

Verfügbar ab:

GlaxoSmithKline UK Ltd

ATC-Code:

R03DX09

INN (Internationale Bezeichnung):

Mepolizumab

Dosierung:

100mg

Darreichungsform:

Powder for solution for injection

Verabreichungsweg:

Subcutaneous

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: 03040200; GTIN: 5000123114672

Gebrauchsinformation

PACKAGE LEAFLET: INFORMATION FOR THE USER
NUCALA
® 100 MG POWDER FOR SOLUTION FOR INJECTION
mepolizumab
This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side effects you may get.
See the end of section 4 for how to
report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Nucala is and what it is used for
2.
What you need to know before you use Nucala
3.
How to use Nucala
4.
Possible side effects
5.
How to store Nucala
6.
Contents of the pack and other information
Step-by-step instructions for use
1.
WHAT NUCALA IS AND WHAT IT IS USED FOR
Nucala contains the active substance MEPOLIZUMAB,
a
_monoclonal antibody_
, a type of protein designed to
recognise a specific target substance in the body. It is used to treat
SEVERE ASTHMA
in adults.
_ _
Some people with severe asthma have too many
_eosinophils_
(a type of white blood cell) in the blood and
lungs. This condition is called
_eosinophilic asthma – _
the type of asthma Nucala can treat.
Nucala can reduce your number of asthma attacks, if you are already
using medicines such as high dose
inhalers, but your asthma is not well controlled by these medicines.
If you are taking medicines called
_oral corticosteroids,_
Nucala can also help reduce the daily dose you need
to control your asthma.
Mepolizumab, the active substance in Nucala, blocks a protein called
_interleukin-5_
. By blocking the action of
this protein
_, _
it limits the production of more eosinophils from the bone marrow and
lowers the number of
eosinophils in the bloodstream and the lungs.
2.
WHAT YOU NEED TO KNOW

Fachinformation

OBJECT 1
NUCALA 100 MG POWDER FOR SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 18-Jun-2018 |
GlaxoSmithKline UK
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
Nucala 100 mg powder for solution for injection
2. Qualitative and quantitative composition
Each vial contains 100 mg mepolizumab. After reconstitution, each ml
of solution contains 100 mg
mepolizumab.
Mepolizumab is a humanised monoclonal antibody produced in Chinese
hamster ovary cells by
recombinant DNA technology.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for solution for injection.
Lyophilised white powder.
4. Clinical particulars
4.1 Therapeutic indications
Nucala is indicated as an add-on treatment for severe refractory
eosinophilic asthma in adult patients (see
section 5.1).
4.2 Posology and method of administration
Nucala should be prescribed by physicians experienced in the diagnosis
and treatment of severe refractory
eosinophilic asthma.
Posology
_Adults _
The recommended dose of mepolizumab is 100 mg administered
subcutaneously once every 4 weeks.
Nucala is intended for long-term treatment. The need for continued
therapy should be considered at least
on an annual basis as determined by physician assessment of the
patient's disease severity and level of
control of exacerbations.
Special populations
_Paediatric population_
The safety and efficacy of Nucala in children and adolescents under 18
years of age has not yet been
established. Very limited data are currently available in children 12
to 18 years old (see sections 4.8, 5.1
and 5.2) therefore no recommendations can be made.
_Elderly patients_
No dose adjustment is required for elderly patients (see section 5.2).
_Renal and hepatic impairment_
No dose adjustment is required in patients with renal or